Feasibility and Safety of Total Percutaneous Closure of Femoral Arterial Access Sites in the Veno-arterial ECMO Patients

Zhejiang University

Status: Unknown

Conditions: Pulmonary Embolism; Hypertension, Pulmonary; Heart Arrest; Myocarditis; Medication Overdoses; Cardiogenic Shock; Extracorporeal Membrane Oxygenation

Study type: Observational

Funder types: Other

Identifiers

NCT04689451

xuxin@GICU

Details and patient eligibility

About

The most frequent access site for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is the common femoral artery (CFA), using either an open or percutaneous technique. Currently, percutaneous closure devices for femoral arterial access sites are approved for use only when a 10-F or smaller sheath has been used. However, the availability of the Perclose ProGlide (Abbott Laboratories, Chicago, IL) device has now made it possible to perform percutaneous vessel closure after using larger sheaths.The preclose technique using Perclose ProGlide, has been widely used in endovascular procedures. In a prospective randomized study, complication rates at the access site were similar in patients who underwent total percutaneous access (including percutaneous arteriotomy closure) than in those who underwent surgical cutdown and subsequent surgical closure. Total percutaneous closure of femoral arterial access sites increases patient comfort and decreases the rate of wound infections and lymphatic fistulas.[6,7] Furthermore, patients are mobilized and discharged earlier following the use of closure devices than with compression alone. Despite the above observations, no data have been published regarding percutaneous closure of femoral artery access sites in patients who have undergone VA-ECMO. In this study, we evaluated the safety and feasibility of a percutaneous closure technique using Perclose ProGlide to close the CFA access site after VA-ECMO.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The study included all patients who underwent VA-ECMO and in whom Perclose ProGlide was deployed to achieve hemostasis during closure of the CFA site.

Exclusion criteria

• Patients were excluded if 24 hour and 30-day follow-up data regarding the access sites and other clinical outcomes were not available.

Trial design

40 participants in 2 patient groups

Perclose ProGlide

Description:

Perclose ProGlide group: use Perclose ProGlide to suture the artery

Surgical Arterial Repair

Description:

Surgical Arterial Repair group : suture the artery by surgery